Composition of a bilirubin stock and a method of preparation thereof

Patent metadata

Field	Value
Publication number	US-11460475-B2
Application number	US-201917265964-A
Country	US
Kind code	B2
Filing date	Jul 31, 2019
Priority date	Aug 9, 2018
Publication date	Oct 4, 2022
Grant date	Oct 4, 2022

Abstract

A composition of a bilimbin stock and a method of preparation are provided. In one aspect of the invention, the composition includes a base solution. The composition further includes a carbonate salt. Additionally, the composition includes bilimbin. Furthermore, the composition includes human serum albumin.

First claim

What is claimed is:

1. A composition of bilirubin stock, wherein the bilirubin stock comprises:
an aqueous base solution comprising at least one chloride salt, at least one phosphate salt, and urea;
a carbonate salt;
bilirubin;
human serum albumin; and
wherein a combination of the carbonate salt, bilirubin, and human serum albumin with respect to the base solution is in a ratio of 4.5:1:7 by weight.

2. The composition of claim 1 , wherein the bilirubin is unconjugated bilirubin.

3. The composition of claim 1 , wherein the at least one chloride salt, at least one phosphate salt, and urea are present in the base solution in a ratio of 1:2.5:0.25 by weight.

4. The composition of claim 1 , further comprising filtered blood plasma.

5. A method of preparing a bilirubin stock, the method comprising:
dissolving a carbonate salt in an aqueous base solution to form a first solution, wherein the aqueous base solution comprises at least one chloride salt, at least one phosphate salt, and urea;
controlling a pH of the first solution such that the pH is in a range of 11 to 12;
dissolving bilirubin in the pH controlled first solution to obtain a second solution;
dissolving human serum albumin in the base solution to obtain a third solution;
controlling a pH of the second solution such that the pH is in a range of 7 to 8; and
adding the third solution to the pH controlled second solution to obtain the bilirubin stock.

6. The method of claim 5 , wherein a combination of the carbonate salt, bilirubin and human serum albumin with respect to the base solution is in a ratio of 4.5:1:7 by weight.

7. The method of claim 5 , wherein the bilirubin is unconjugated bilirubin.

8. The method of claim 5 , wherein the at least one chloride salt, at least one phosphate salt, and urea are present in the base solution in a ratio of 1:2.5:0.25, respectively, by weight.

9. The method of claim 5 , further comprising adding filtered blood plasma to the bilirubin stock.

10. A process of preparation of a bilirubin stock, the process comprising the steps of:
controlling a pH of a first solution to be in a range of 11 to 12, wherein the first solution comprises a carbonate salt;
dissolving bilirubin in the first solution to obtain a second solution;
dissolving human serum albumin in an aqeuous base solution to obtain a third solution, wherein the aqueous base solution comprises at least one chloride salt, at least one phosphate salt, and urea;
controlling a pH of the second solution to be in a range of 7 to 8; and
adding a portion of the third solution to the second solution to obtain the bilirubin stock.

11. The process of claim 10 , wherein the bilirubin is unconjugated bilirubin.

12. The process of claim 10 , wherein the first solution comprises a carbonate salt dissolved in the base solution.

13. The process of claim 10 , wherein the at least one chloride salt, at least one phosphate salt, and urea are present in the base solution at a ratio of 1:2.5:0.25, respectively, by weight.

14. The process of claim 10 , wherein a combination of the carbonate salt, bilirubin and human serum albumin with respect to the base solution is in a ratio of 4.5:1:7 by weight.

15. The process of claim 10 , further comprising adding filtered blood plasma to the bilirubin stock.

16. A kit for preparing a bilirubin stock, the kit comprising:
an aqueous base solution comprising at least one chloride salt, at least one phosphate salt, and urea present at a ratio of 1:2.5:0.25, respectively, by weight;
a first solution, wherein the first solution comprises a carbonate salt;
bilirubin; and
human serum albumin.

Assignees

• Siemens Healthcare Diagnostics Inc

Inventors

• Galgalkar Sudipa
• Chakraborty Ishita
• Ms Ragavendar
• Ledden David

Classifications

• G01N1/38

  Diluting, dispersing or mixing samples · CPC title

• G01N33/72 Primary

  involving blood pigments, e.g. haemoglobin, bilirubin {or other porphyrins; involving occult blood} · CPC title

• Y10T436/103332

  Bilirubin or uric acid standard or control · CPC title

• G01N2496/00

  Reference solutions for assays of biological material · CPC title

• G01N2001/2893

  Preparing calibration standards · CPC title